None listed
Conditions
Brief summary
This project aims to observe the effects of an endoscopic sleeve gastroplasty utilising the overstitch procedure for the treatment of obesity and diabetes which is an increasing problem in our community. During the procedure, a small tube (the endoscope) is inserted through your mouth and passed down your oesophagus into the stomach and proximal small bowel for visual examination of the upper gut by the physician. The endoscope will be removed and provided the endoscopic examination of your upper gut was normal a stitching device (Overstitch, Apollo Endosurgery) will be attached to the endoscope tip. Then the endoscope will be reinserted and used to stitch the walls of the stomach together to create a smaller volume residual stomach in the form of a tube. This usually requires between 3 and 5 stitches to be placed. These stitches will remain in the stomach indefinitely but can potentially be removed if required. This study will also look to assess the following outcomes • Weight loss - assessed via weight on digital scales at each appointment • Health related quality of life as measured by the SF-36v2 • Psychological wellbeing measured by the Hospital Anxiety and Depression Scale • Pancreatic exocrine functional testing as measured by a 13C labeled mixed triglyceride breath test as measured by a 13C labeled mixed triglyceride breath test • Fasting insulin measured via blood assay • Composite secondary outcome measure of cardiopulmonary reserve and exercise capacity measured by a 6 minute walk test • Fasting Blood glucose measured by blood assay • Stool microbiome community profiling will enable characterisation of the bacterial diversity of the gastric and duodenal mucosa-associated microbiome. • Gastric emptying as measured by 13C Octanoid breath test • Liver function measured by non-invasive hepatic elastography. • Body composition assessment as measured by Dual-energy X-ray absorptiometry • Visceral sensitivity as measured by a Standard Nutrient challenge test. • Self reported diet quality as measured by diet history and 24 hour recall • Gastrointestinal This study will enroll 15 obese type 2 diabetic patients (males and females) recruited from the “Obesity clinic” run by the Department of Endocrinology, general practice referrals or on the waiting list for another study HREC/QPAH/15/246. Patients will be followed up for a period of 1 year from the time of procedure and assessed for changes in the above mentioned variables throughout the follow up period. The data will be compared to the study group baseline characteristics and to the results of a currently still ongoing trial conducted at our Department. In this ongoing trial a group of 15 patients underwent a temporary duodenaljejunal bypass sleeve insertion (HREC/QPAH/15/246).
Interventions
This project will be a single centre, one-armed interventional trial. 15 patients will undergo an endoscopic sleeve gastroplasty (ESG) procedure. During the procedure, a small tube (the endoscope) is inserted through the mouth and passed down the oesophagus into the stomach and proximal small bowel for visual examination of the upper gut by the physician. The endoscope will be removed and provided the endoscopic examination of the upper gut is normal a stitching device (Overstitch, Apollo Endosu
This project will be a single centre, one-armed interventional trial. 15 patients will undergo an endoscopic sleeve gastroplasty (ESG) procedure. During the procedure, a small tube (the endoscope) is inserted through the mouth and passed down the oesophagus into the stomach and proximal small bowel for visual examination of the upper gut by the physician. The endoscope will be removed and provided the endoscopic examination of the upper gut is normal a stitching device (Overstitch, Apollo Endosurgery) will be attached to the endoscope tip. Then the endoscope will be re-inserted and used to stitch the walls of the stomach together to create a smaller volume residual stomach in the form of a tube. This usually requires between 3 and 5 stitches to be placed. These stitches will remain in the stomach indefinitely but can potentially be removed if required. After the procedure the physician will assess and decide if a patient can be discharged the same day or if they may need to stay overnight in hospital so the physician can monitor and treat potential post-procedural symptoms (e.g. nausea, discomfort). Investigations will be performed at baseline, immediately prior to their ESG and following their ESG procedure. Patients will follow our protocolled testing as well as medical and allied health protocolled review as per our follow up schedule over a 12 month follow up period.
Sponsors
Princess Alexandra Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 18 and 65 years. 2. Functional level equivalent to an ECOG score of 2 or less. 3. Obese – BMI >35 kg/m2. 4. Type II diabetes mellitus on oral hypoglycaemic agents but not insulin. 5. English speaking. 6. Willing to participate in a 1 year trial and with capacity to consent.
Exclusion criteria
Exclusion criteria prior to recruitment will include: 1. Prior gastric or intestinal surgery including (not exclusively) the following: a. Nissen Fundoplication, gastrectomy, b. Vertical Banded Gastroplasty, Gastric Bypass, gastric partitioning, gastric stapling, gastric resection, placement of the LAPBAND™ System, c. Small bowel resection, colon resection, colostomy, 2. Any inflammatory disease of the gastrointestinal tract including oesophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn’s disease. 3. Potential upper gastrointestinal bleeding conditions such as oesophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses. 4. A large hiatal hernia. 5. A structural abnormality in the oesophagus or pharynx such as a stricture or significant diverticulum. 6. Significant coronary artery disease. (Previous myocardial infarction or angina in the past 90 days.) 7. Any medical condition that requires or is likely to require anticoagulation or dual anti-platelet therapy during the study period. 8. Any active malignancy. 9. Any medical condition with a likely survival of 5 years or less. 10. Any patient likely to require abdominal surgery during the study period. 11. Patient or family history of connective tissue disease. 12. Patient or family history of gastric precancerous or cancerous lesions 13. Any upper gastrointestinal abnormality or anatomical variant that may interfere with this procedure. 14. Pregnancy. 15. Known chronic pancreatitis. 16. Poor functional status ECOG greater than or equal to 3. 17. Antibiotic use at the time of endoscopy. 18. Any other medical condition, which would not permit elective endoscopy. 19. Major prior or present psychological or psychiatric disorder including alcoholism or drug addiction. Exclusion criteria after recruitment will include: 1. Inadequate cardiopulmonary reserve for anaesthetisation. 2. Structural or mucosal abnormality found during upper endoscopy that would preclude an endoscopic sleeve gastroplasty. 3. Withdrawal of consent. 4. Clinician concern regarding any of the above exclusion criteria.
Outcome results
None listed